FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
25321–25344 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 26, 2018
Avologi ENEO
K181659 · OHS
Premier North America, Inc.
General & Plastic Surgery · 31d
Cleared Jul 26, 2018
Level 1 Convective Warmer
K181699 · DWJ
Smiths Medical Asd, Inc.
Cardiovascular · 29d
Cleared Jul 26, 2018
neuromate Gen III
K181706 · HAW
Renishaw Mayfield Sarl
Neurology · 28d
Cleared Jul 26, 2018
San Antonio Stopcock
K181712 · ODC
Cook Incorporated
Gastroenterology & Urology · 28d
Cleared Jul 26, 2018
CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
K181790 · NGL
Hangzhou Clongene Biotech Co., Ltd.
Toxicology · 21d
Cleared Jul 26, 2018
RadialSeal Introducer Kit
K181855 · DYB
Great Batch Medical
Cardiovascular · 15d
Cleared Jul 25, 2018
RHYTHMIA HDx Mapping System (with software Version 2.0)
K173837 · DQK
Boston Scientific Corporation
Cardiovascular · 219d
Cleared Jul 25, 2018
Lumbar Interbody Fusion System (OLLIF)
K173947 · MAX
Advanced Research Medical, LLC
Orthopedic · 210d
Cleared Jul 25, 2018
TREND II Spinal Fixation System- STEP Series
K180226 · NKB
Paonan Biotech Co., Ltd.
Orthopedic · 180d
Cleared Jul 25, 2018
Smartinhaler
K180407 · CAF
Adherium (Nz), Ltd.
Anesthesiology · 161d
Cleared Jul 25, 2018
Exactech Equinoxe Small Reverse Shoulder System
K180632 · PHX
Exactech, Inc.
Orthopedic · 135d
Cleared Jul 25, 2018
Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit,...
K180752 · HIH
Corinth Medtech, Inc.
Obstetrics & Gynecology · 125d
Cleared Jul 25, 2018
FIXIT / ComposiTCP Threaded Anchor System
K180960 · MAI
S.B.M. Sas Sciences For Bio Materials
Orthopedic · 104d
Cleared Jul 25, 2018
ATEC ALIF Spacer System
K181453 · MAX
Alphatec Spine, Inc.
Orthopedic · 54d
Cleared Jul 25, 2018
Republic Spine Dark Star Spinal System
K181495 · NKB
Republic Spine, LLC
Orthopedic · 49d
Cleared Jul 25, 2018
Alphenix, INFX-8000V/B, V8.0
K181670 · OWB
Canon Medical Systems Corporation
Radiology · 30d
Cleared Jul 24, 2018
Autokeeper
K172095 · FMI
Medexel Co.,Ltd
General Hospital · 378d
Cleared Jul 24, 2018
Portable ECG Monitor (ECG3)
K172862 · DSH
Andon Health Co, Ltd.
Cardiovascular · 307d
Cleared Jul 24, 2018
CipherOx CRI M1
K173929 · PPW
Flashback Technologies, Inc.
Cardiovascular · 210d
Cleared Jul 24, 2018
Dental High-speed Handpiece and Accessories
K173943 · EFB
Microp Technology (Taiwan), Inc.
Dental · 210d
Cleared Jul 24, 2018
MX40 Release C.01
K180017 · MHX
Philips Medical Systems
Cardiovascular · 203d
Cleared Jul 24, 2018
TWBM Pump
K180115 · JCX
Taiwan Biomaterial Co., Ltd.
General & Plastic Surgery · 189d
Cleared Jul 24, 2018
Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal...
K180218 · OCC
Cepheid
Microbiology · 180d
Cleared Jul 24, 2018
DePuy Synthes Static Staples
K180544 · JDR
Synthes USA Products, LLC
Orthopedic · 145d